BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAP-BAND AP LARGE WITH RAPIDPORT EZ

    MDR report key: 4990519 · Received August 7, 2015

    Report

    Report Number
    3006722112-2015-00267
    Event Type
    Injury
    Date Received
    August 7, 2015
    Date of Event
    July 7, 2015
    Report Date
    July 9, 2015
    Manufacturer
    APOLLO ENDOSURGERY, INC.
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    1

    Narratives

    Additional Manufacturer Narrative · 1

    SUPPLEMENT #2. THE DEVICE WAS RETURNED TO APOLLO, BUT ONLY THE BAND PORTION OF THE DEVICE WAS RECEIVED. WITHOUT THE PORT, VISUAL EXAMINATION COULD NOT CONFIRM THE CONNECTER TYPE ASSOCIATED WITH THIS COMPLAINT. BASED ON THE PREVIOUSLY PROVIDED SERIAL NUMBER, IT IS ASSUMED THIS DEVICE'S ACCESS PORT CONFIGURATION WAS A RAPIDPORT EZ STRAIN RELIEF. DEVICE EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR ANALYSIS, AND ONLY THE BAND PORTION OF THE DEVICE WAS RECEIVED. VISUAL INSPECTION NOTED AREAS OF DISCOLORATION ON THE DEVICE. ANALYSIS OF THE DEVICE NOTED A SEPARATION BETWEEN THE END PLUG AND SHELL. THE DEVICE WAS TESTED FOR LEAKAGE, AND BUBBLES WERE OBSERVED COMING FROM THE END PLUG/SHELL JUNCTION SITE. ANALYSIS OF THE OPENING ON THE SHELL FOUND THERE WAS AN ADHESIVE ISSUE NOTED AS ADHESIVE FAILURE.

    Additional Manufacturer Narrative · 1

    RAPIDPORT EZ STRAIN RELIEF BASED ON THE SERIAL NUMBER PROVIDED, IT IS ASSUMED THIS DEVICE'S ACCESS PORT CONFIGURATION WAS A RAPIDPORT EZ STRAIN RELIEF. VISUAL EXAMINATION MAY CONFIRM OR DETERMINE ANOTHER CONNECTOR TYPE ASSOCIATED WITH THIS REPORT. DEVICE RETURN WAS REQUESTED OF THE REPORTER. TO DATE, THE DEVICE HAS NOT BEEN RECEIVED BY APOLLO.

    Additional Manufacturer Narrative · 1

    UNK TAPER. THE PRODUCT ASSOCIATED WITH THIS REPORT HAS NOT YET BEEN RETURNED. THE REPORTER OF THE EVENT STATED THE PRODUCT WILL BE RETURNED FOR ANALYSIS. VISUAL EXAMINATION MAY CONFIRM OR DETERMINE CONNECTOR TYPE ASSOCIATED WITH THIS REPORT. FURTHER INFORMATION FROM THE REPORTER REGARDING THE SERIAL NUMBER AND THE IMPLANT DATE HAS BEEN REQUESTED. DEVICE LABELING ADDRESSES THE POSSIBLE OUTCOME OF LEAK AS FOLLOWS: "UNPLANNED DEFLATION OF THE BAND MAY OCCUR DUE TO LEAKAGE FROM THE BAND, THE PORT OR THE CONNECTING TUBING."

    Description of Event or Problem · 1

    REPORTED AS: PATIENT CONTACTED THE SURGEON COMPLAINING OF NOT LOSING WEIGHT. SURGEON PERFORMED A LAPAROSCOPIC PROCEDURE AND FOUND THE SEAM OF THE SHELL WAS LEAKING. SURGEON REMOVED THE LAP-BAND SYSTEM AND REPLACED IT WITH A NEW LAP-BAND SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    521004 LAP-BAND AP LARGE WITH RAPIDPORT EZ ADJUSTABLE GASTRIC BAND LTI APOLLO ENDOSURGERY, INC. AP LARGE 2030960

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention